MedCAD® AccuPlate® 3DTi Patient-Specific Plating System
FDA 510(k) K230398 · Medcad
510(k) numberK230398
Submission
- Device name
- MedCAD® AccuPlate® 3DTi Patient-Specific Plating System
- Applicant
- Medcad
Dallas, TX, US - Received
- February 16, 2023
- Decision date
- September 26, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K220357 | MedCAD AccuShape Titanium Patient-Specific Cranial ImplantGXN · Traditional | 08/26/2022SE |
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| K192282 | MedCAD® AccuPlan® SystemDZJ · Traditional | 10/29/2020SE |
Questions and answers
When was MedCAD® AccuPlate® 3DTi Patient-Specific Plating System cleared by the FDA?
MedCAD® AccuPlate® 3DTi Patient-Specific Plating System (K230398) received a 510(k) decision of Substantially Equivalent on September 26, 2023, 222 days after the submission was received.
What is the product code of K230398?
The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.